NCT00947310已完成不适用
IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Inappropriate ICD Therapy
研究概览
简要总结
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
详细描述
The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
- •Patient in sinus rhythm
- •Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
- •Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent
排除标准
- •Patient with an implanted pacemaker or CRT-P
- •Patient with existing ICD or CRT-D device components
- •Patient with a history of VT or VF
- •Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
- •Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
- •Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
- •Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- •Patient with second or third degree heart block
- •Patient in NYHA Class IV
- •Patient who is pregnant or plans to become pregnant during the course of the trial
- •Patient with irreversible brain damage from preexisting cerebral disease
- •Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
- •Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl
- •Patient participating in any other clinical trial
- •Patient unwilling or unable to cooperate with the protocol
- •Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
- •Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
- •Patient unwilling to sign the consent for participation
- •Patient whose physician does not allow participation
研究组 & 干预措施
A
Experimental
Standard ICD Programming
干预措施: Standard ICD programming (Device)
B
Experimental
High rate cutoff
干预措施: High rate cutoff (Device)
C
Experimental
Long ICD duration delay
干预措施: Long delay (Device)
结局指标
主要结局
Inappropriate ICD Therapy
时间窗: Average of 1.4 years follow-up
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
次要结局
- All-cause Mortality(Average 1.4 years of follow-up)
- Syncope(Average of 1.4 years follow-up)
研究者
研究点 (1)
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